On May 24, 2022 Sysmex Inostics, a global leader in the liquid biopsy revolution, reported that it has expanded its offering of CLIA-validated tests to include AML-SEQ, a focused panel to detect mutations of the three most prevalent genes found in Acute Myeloid Leukemia (AML) – IDH1/2 & NPM1 (Press release, Sysmex Inostics, MAY 24, 2022, View Source [SID1234614984]).
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AML-SEQ rounds out the company’s AML Laboratory Developed Test (LDT) offerings with a less expensive test compared to the broader AML-MRD-SEQ panel launched in October 2021. AML-MRD-SEQ is a more extensive panel for the detection of measurable residual disease (MRD) in 68 regions across 20 genes including the clinically established IDH1/2 and NPM1.
"We envision investigators and eventually physicians using AML-SEQ and AML-MRD-SEQ as a one-two-punch in the fight against AML and AML MRD. We are committed to developing tools to support the fight against this devastating disease. We must support management of patients suffering from AML by providing the accurate and sensitive detection of AML biomarkers," said Shinichi Sato, CEO of Sysmex Inostics, Inc.
AML-SEQ adds to the portfolio of ultra-sensitive Plasma-Safe-SeqS technology NGS tests available through Sysmex Inostics’ CLIA lab services in Baltimore, Maryland.
Joins Foundation for the National Institutes of Health Biomarkers Consortium
The FNIH consortium combines significant public and private organizations to develop AML MRD guidelines, establish methods for MRD detection, and achieve better measures for clinical trial design and drug development. Project partners include the National Cancer Institute (NCI), the National Heart Lung and Blood Institute (NHLBI), the U.S. Food and Drug Administration (FDA), several award-winning cancer institutions and leading pharmaceutical and diagnostic companies. For more information about the FNIH AML-MRD Consortium click here.
According to the National Cancer Institute (NCI), an estimated 20,050 new AML cases will be diagnosed in the United States in 2022.1 Rising incidence of cancer and increasing preference of noninvasive treatments is driving the quick expansion of the liquid biopsy market. Globally, the liquid biopsy market is to achieve an annual growth rate of more than 18% over the next few years, reaching $5.8 billion by 2026.2